E-Cigs Need Approval, FDA Says

WASHINGTON -- The FDA has sent letters to five manufacturers of electronic cigarettes warning that they are in violation of federal law by claiming their products help smokers quit.

In order to make such claims, the e-cigarettes would need to be approved by the FDA as drug-delivery devices, the agency said. None are.

E-cigarettes are battery powered metallic tubes that resemble traditional cigarettes and are filled with a liquid nicotine mixture derived from tobacco, as well as flavors and other chemicals. The liquid is converted into a vapor that the user inhales.

E-cigarettes contain no health warnings, as conventional cigarettes and other FDA-approved nicotine replacement products do, and little is known about the safety of the devices. No e-cigarette company has submitted an application to the FDA for evaluation or approval, the agency said, although the devices meet the definition of a drug-device product under the Food, Drug, and Cosmetic Act (FDCA).

Under that act, a company can't claim its product can treat or mitigate a disease, such as nicotine addiction, unless the FDA has confirmed the drug is safe and effective.

"Although these products are frequently marketed to help consumers quit smoking, the FDA has not evaluated them for safety or effectiveness," said Michael Levy, director of the agency's Division of New Drugs and Labeling Compliance in the Center for Drug Evaluation and Research (CDER) on a call with reporters.

The companies were also cited for not adhering to proper manufacturing processes.

The warning letters went to E-CigaretteDirect of Parker, Colo.; Ruyan America of Minneapolis; Gamucci America, also known as Smokey Bayou, of Jacksonville, Fla.; E-Cig Technology of Las Vegas; and Johnson's Creek Enterprises, based in Johnson, Wis.

E-Cig Technology received an additional warning for illegally marketing an unapproved erectile dysfunction drug called tadalafil, as well as an unapproved weight-loss drug called rimonabant to refill empty e-cigarette cartridges.

Johnson's Creek Enterprises was also cited for failing to establish quality control and testing procedures.

The FDA also sent a letter Thursday to the Electronic Cigarette Association, informing the group that the FDA intends to regulate e-cigarettes "in a manner consistent with its mission of protecting the public health."

In that letter, Janet Woodcock, MD, the director of the FDA's Center for Drug Evaluation and Research said the e-cigarettes included in the warning letters meet the definition of a drug, a device, and a drug-delivery device.

She explained that in order to continue to market their e-cigarettes in the manner they have been, the companies would have to undergo the lengthy FDA approval process required of new drugs and devices.

It has been more than a year since President Obama signed the Family Smoking Prevention and Tobacco Control Act, giving the FDA the authority to regulate tobacco products. The law banned flavors from traditional cigarettes but didn't lay out any explicit rules on electronic cigarettes.

However, the FDA has clearly had its eye on e-cigarettes -- early this summer the agency released results of lab tests that revealed e-cigarettes contain carcinogens including diethylene glycol, used in antifreeze, and nitrosamines.

The agency is currently involved in a lawsuit with other e-cigarette companies challenging the agency's jurisdiction over the devices.

"FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the U.S. are lawfully marketed," Woodcock wrote.

The firms have 15 days to respond to the FDA's letter.

Bill Bartkowski, president of Ruyan America, told MedPage Today that his company hasn't sold any e-cigarettes or tobacco products in the U.S. since May of 2009 because of the growing ambiguity that has come with tighter government regulation of tobacco products over the past year.

"I think the Family Smoking and Prevention Act makes it pretty clear that, one way or the other, the FDA is going to regulate this."

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